Chemoembolisation of Non Resectable, Non Metastatic Hepatocellular Carcinomas

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

18 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-12-31

Study Completion Date

2012-06-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The purpose of this study is to determine the maximal tolerated dose of idarubicin for chemoembolization of non resectable non metastatic hepatocellular carcinoma.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Chemoembolization of Non-resectable Non-metastatic Hepatocellular Carcinoma Using Embolization Microspheres

NCT02870010

Localized Non-Resectable Adult Hepatocellular Carcinoma

COMPLETED PHASE1

Chemoembolisation of Hepatocellular Carcinomas Not Subject to Interventive Care by Idarubicin-loaded Beads - IDASPHERE II

NCT02185768

Liver Cancer

COMPLETED PHASE2

Radioembolization With Yttrium-90 Microspheres for Intermediate or Advanced Hepatocellular Carcinoma

NCT00910572

Hepatocellular Carcinoma Liver Cancer

COMPLETED PHASE2

Safety and Efficacy Study of Radioembolization in Combination With Durvalumab in Locally Advanced and Unresectable HCC

NCT04124991

Hepatocellular Carcinoma

COMPLETED PHASE1/PHASE2

Lipiodol-TACE With Idarubicin for Hepatocellular Carcinoma

NCT05280444

Hepatocellular Carcinoma

UNKNOWN PHASE2/PHASE3

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Hepatocellular carcinoma (HCC) is the fifth most common malignancy and the third most common cause of cancer-related death worldwide. Most of the patients are diagnosed at intermediate-advanced stage when the sole standard treatment is transarterial chemoembolization (TACE). In the literature, survival rates in TACE studies vary widely and finally, there is no suggestion for the best chemotherapeutic agent or the optimal treatment regimen.

We hypothesise that the use of idarubicin (the most cytotoxic drug on HCC cell lines) in DC Bead would enhance the efficacy of TACE. The primary objective of the study is to determine the maximal tolerated dose of idarubicin in DC Bead for chemoembolization of non resectable non metastatic hepatocellular carcinoma.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Carcinoma, Hepatocellular

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Idarubicin

Dose escalation: level0 = idarubicin 5mg, level1 = idarubicin 10mg, level2 = idarubicin 15mg, level3 = idarubicin 20mg, level4 = idarubicin 25mg

Group Type EXPERIMENTAL

idarubicin

Intervention Type DRUG

Transarterial chemoembolization (in the hepatic artery) with idarubicin 5mg or 10 mg or 15 mg or 20 mg or 25 mg injected in a solution of 2ml DC Bead (300 µm-500µm); 1 unique course

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

idarubicin

Transarterial chemoembolization (in the hepatic artery) with idarubicin 5mg or 10 mg or 15 mg or 20 mg or 25 mg injected in a solution of 2ml DC Bead (300 µm-500µm); 1 unique course

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

4-MDR IMI 30 IDA

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Hepatocellular carcinoma cytologically or histologically proved or diagnosed according the criteria of the American Association for the Study of Liver Diseases(AASLD 2005)
* Three nodules maximum (unilobar disease without limitation in the number of nodules; 3 maximum nodules if bilobar disease \[satellite nodules \<1cm not included in the total sum\])
* Child-Pugh score A or B7
* ECOG Performance Status \< 2
* Platelet count \> 50,000/µl and absolute neutrophil count (ANC) \>1,000/µl
* Serum creatinine \< 150 µmol/l
* Resting ejection fraction \> 50% (echocardiography or isotopic method)
* Age \> 18 years
* Signed written informed consent

Exclusion Criteria

* Patients eligible for surgical resection or hepatic transplantation or radiofrequency ablation
* Extrahepatic metastases
* Known gastrointestinal bleeding up to 30 days before study entry
* Patients with anticoagulant treatment
* Evidence of portal vein thrombosis
* Pregnancy
* Clinically serious infection
* Known hypersensitivity to anthracyclines
* Known hypersensitivity to contrast medium

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No